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A Study on the Safety and Efficacy of Nitric Oxide Gel in Subjects With Painful Diabetic Neuropathy

This study is currently recruiting participants.
Verified February 2013 by China Medical University Hospital
Sponsor:
Information provided by (Responsible Party):
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT01633086
First received: May 30, 2012
Last updated: February 12, 2013
Last verified: February 2013
History of Changes
  Purpose

Neuropathic pain is a common symptom of diabetic neuropathy, and predominantly involves the lower limbs. Current strategies for the management of painful diabetic neuropathy include improved glycemic control, use of analgesics and addition of tricyclic antidepressants and anticonvulsants. However, many patients experience unsatisfactory responses and some undesired side effects. Considerable evidence implicates impaired nitric oxide synthesis plays an important role in the pathogenesis of diabetic neuropathic pain. Several small studies have shown that topical nitroglycerin ointment has local vasodilating properties, and a previous study has demonstrated that isosorbide dinitrate in spray form as a nitric oxide donor relieved some neuropathic symptoms in patients with painful diabetic neuropathy. Based on the findings, the investigators hypothesize that nitric oxide gel could be used as an alternative pain-relieving agent for patients with resistant diabetic neuropathic pain.


Condition Intervention Phase
Neuropathic Pain
 Drug: nitric oxide gel
Drug: placebo gel
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Study on the Safety and Efficacy of Nitric Oxide Gel in Subjects With Painful Diabetic Neuropathy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by China Medical University Hospital:

Primary Outcome Measures:
  • Neuopathic Pain Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • vascular duplex parameters [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • the likelihood of reusing the nitric oxide gel recorded [ Time Frame: 12weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: July 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: nitric oxide gel
  1. st gel: sodium nitrites
  2. nd gel: maleic/ascorbic acids
 Drug: nitric oxide gel
  1. st gel: sodium nitrites,BID local use X 28 days
  2. nd gel: maleic/ascorbic acids ,BID local use X 28 days
Placebo Comparator: Placebo gel Drug: placebo gel
placebo gel,BID local use X 28 days

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects>=30 and<=80 years of age.
  2. Subjects with type 1 or type 2 diabetes mellitus with painful diabetic neuropathy.
  3. Subjects without undergoing treatment for painful diabetic neuropathy or with treatment for at least 3 months but still presenting neuropathic pain prior to randomization.
  4. Subjects who are healthy without any serious diseases that require hospitalization during the study period.
  5. Subjects who are capable of understanding and having signed the Informed Consent Form after detailed description of the treatment procedures and potential risks and benefits.

Exclusion Criteria:

  1. Subjects with diagnosis of cancer and are still on active therapies.
  2. Subjects with diagnosis of an active disease (e.g. hyper-or-hypothyroidism, advanced chronic renal failure, severe anemia, liver cirrhosis, active infectious disease etc.) and are still under regular treatment for this disease
  3. Subjects with peripheral neuropathy caused by a known acute or chronic disease or injury
  4. Subjects who are on other medications with pharmacological actions that may lead to excessive formation of nitric oxide (e.g. sublingual nitroglycerin, sildanafil etc.) or may accentuate drug effects due to excessive formation of nitric oxide.
  5. Subjects with severe peripheral artery disease leading to absence of foot pulses.
  6. Subjects with erratic glycemic control (HbA1c 12).
  7. Subjects with an active foot ulceration or infection.
  8. Subjects with any known allergic reaction to any ingredient in the 2 gel preparations.
  9. Subjects who have been enrolled into any clinical study in the preceding 3 months prior to randomization.
  10. Subjects with current substance or alcohol abuse that in the opinion of the investigator would interfere with compliance or with interpretation of the study result
  11. Female subject of childbearing potential who is lactating or has positive urine pregnancy test at V0 or refuses to adop reliable method of contraception during the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01633086

Contacts
Contact: Ching-Chu Chen, Dr 886-4-22062121 ext 3489 chingchu@ms15.hinet.net

Locations
Taiwan
China Medical University Hospital Recruiting
Taichung, Taiwan, 404
Contact: Ching-Chu Chen, M.D     886-4-22062121 ext 3489     chingchu@ms15.hinet.net    
Sponsors and Collaborators
China Medical University Hospital
Investigators
Principal Investigator: Ching Chu Chen, M.D. China Medical University Hospital
Study Director: Ching-Chu Chen, M.D China Medical University Hospital
  More Information

No publications provided

Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT01633086     History of Changes
Other Study ID Numbers: DMR99-IRB-273
Study First Received: May 30, 2012
Last Updated: February 12, 2013
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Diabetic Neuropathies
Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Protective Agents

ClinicalTrials.gov processed this record on May 23, 2013